FDA Approves New Morning-After Pill

The Food and Drug Administration approved a version of the morning-after pill Friday that can be taken later after sex. The new drug, ella, can prevent pregnancy when taken up to five days after unprotected sex or contraception failure. Plan B, the existing morning-after pill, works for up to three days following intercourse.

Unlike Plan B and its other generic versions, which can be bought by women 17 and older over the counter, ella will be available only by prescription.

The pill uses the hormone progesterone to delay ovulation. According to the FDA, ella is not intended for routine use as a contraceptive.

The drug, manufactured by Paris-based Laboratoire HRA Pharma, has been available in Europe under the brand name EllaOne since May 2009. It will be distributed in the U.S. by Watson Pharmaceuticals in Morristown, N.J.

Ella’s approval comes after an advisory panel unanimously backed the emergency contraceptive drug in June. Two separate clinical trials were used to demonstrate the pill’s safety and efficiency. One trial was conducted solely in the U.S., and the other was conducted in the U.S., the U.K. and Ireland.

According to USA Today, a head-to-head trial between the two drugs conducted by ella’s manufacturer showed that women who took ella had a 1.8% chance of becoming pregnant, while women who took Plan B had a 2.6% chance.

Like Plan B, ella’s side effects include headache, nausea, stomach pain, fatigue, dizziness and menstrual pain or discomfort. Additionally, women with known or suspected pregnancy and women who are breastfeeding should not take the pill.